"Biomedical research on potentially dangerous pathogens can be performed safely and is essential," the new, 36-member group said in a statement quoted by the news service on Wednesday. The signers included Yoshihiro Kawaoka of the University of Wisconsin-Madison and Ron Fouchier of Erasmus Medical Center in the Netherlands, key proponents of research that can produce deadlier forms of avian influenza.

The "Scientists for Science" coalition issued the remarks on the heels of several safety incidents at the U.S. Centers for Disease Control and Prevention, including an unintended transfer of avian flu from its headquarters in Atlanta. A second lapse prompted fears that dozens of CDC workers had been exposed to anthrax, shortly before workers in Maryland discovered a cache of forgotten smallpox samples at a Food and Drug Administration facility.

The new group's members said such incidents highlight the importance of safety measures at laboratories responsible for handling dangerous disease agents. However, they cautioned against restricting research conducted at such sites.

Subscribe to Biodefense News Newsletter

WASHINGTON, D.C. (October 11, 2018) – America’s hometown heroes are on the front line when responding to biological incidents. These include health care providers, public health professionals, EMTs, firefighters and police. But a new report from the Blue Ribbon Study Panel on Biodefense says the thousands of first responders at state, local, tribal, and territorial (SLTT) governments that form the backbone of our nation will have to fend for themselves for far too long until federal assets arrive to assist with response. Holding the Line on Biodefense: State, Local, Tribal, and Territorial Reinforcements Needed recommends eight key steps that will increase the capability of the SLTT public and private sectors to share with the federal government the burden of preparing for, responding to, and recovering from large-scale biological events.

“How we respond to biological events – especially those large in scale and impact – is now out of balance with how we prepare,” said former Secretary of Health and Human Services Donna Shalala, Panel Member, who co-chaired the January 2018 meeting in Miami that informed many of the report’s recommendations. “There are a number of steps we can take right now to better position SLTT governments, as well as hospitals, pharmacies, and other private sector organizations to respond immediately and then in tandem with federal support.”

The eight recommendations are:

• Unify and establish a new National Emergency Medical Services system, including the creation of a National Emergency Medical Services Agency at the Department of Health and Human Services.

• Improve distribution of the Strategic National Stockpile and other stores of pharmaceuticals, equipment, and essential medical supplies, with enhanced training and assured access to pharmacy readiness data.

• Layer health care delivery across the nation and plan for when hospitals and other facilities are overwhelmed and overrun.

WASHINGTON — Three years after discovering that a military laboratory had shipped live anthrax to facilities around the world, the Department of Defense still has not developed a plan to evaluate its biological security practices, the federal Government Accountability Office reported on Thursday.

The department has implemented about half of the procedural changes that had been recommended, the G.A.O. said. But the Pentagon still has not established a way to measure the effectiveness of these reforms, making it difficult for experts to determine whether safety has improved.

“When it comes to reforming procedures, this is not a one-off thing that you can do once and take a vacation,” said Gigi Gronvall, a biosecurity expert at the Johns Hopkins Center for Health Security.

“We must be careful that the evaluations and procedures intended to increase safety actually do that,” she added.

New genetic tools are making it easier and cheaper to engineer viruses and bacteria, and a report commissioned by the Department of Defense has now ranked the top threats posed by the rapidly advancing field of "synthetic biology."

One of the biggest concerns is the ability to recreate known viruses from scratch in the lab. That means a lab could make a deadly virus that is normally kept under lock and key, such as smallpox.

"Right now, recreating pretty much any virus can be done relatively easily. It requires a certain amount of expertise and resources and knowledge," says Michael Imperiale, a microbiologist at the University of Michigan who chaired the committee convened by the National Academies of Sciences, Engineering, and Medicine to assess the state of synthetic biology and offer advice to defense officials.

As an example of what's possible, Imperiale pointed to the recent and controversial creation of horsepox, a cousin of smallpox, in a Canadian laboratory. "These things can now be done," he said.

Another top danger listed in the report, which was released Tuesday, is making existing bacteria or viruses more dangerous. That could happen, by, say, giving them antibiotic resistance or altering them so that they produce toxins or evade vaccines.

And one scenario pondered by the experts is the creation of microbes that would produce harmful biochemicals in humans while living on the skin or in the gut. This possibility, the report notes, "is of high concern because its novelty challenges potential mitigation options." Public health officials might not even recognize that they were witnessing a biological attack if the dangerous material was delivered to victims in such an unusual way.

All in all, the committee examined about a dozen different synthetic biology technologies that could be potentially misused. For each, they considered how likely it was to be usable as a weapon, how much expertise or resources would be needed, and how well governments would be able to recognize and manage an attack.

"There are certain capabilities that may not be possible now, but in those cases we tried to identify what the bottlenecks or barriers might be that, if overcome, would enable those to be more possible," Imperiale says.

One of the least concerning possibilities, because of the knowledge and technical barriers, was inventing a brand new pathogen by taking a "mix and match" approach to combining genetic parts from multiple organisms, according to the report. It notes that making even simple changes to viruses can produce "drastic deficiencies" in key viral properties, "making any such effort especially difficult," and that "the difficulty increases as the distance from natural pathogens increases."

But that was exactly the scenario that recently unfolded in a table-top exercise conducted last month by the Johns Hopkins Center for Health Security. During the event, experts in pandemic response and national security grappled with a fictional virus called "Clade X" that was created by a terrorist group that inserted genetic elements of deadly Nipah virus into a normally-mild human parainfluenza virus.

The terrorist group in this scenario wanted to depopulate the Earth, and deliberately released the contagious virus at multiple spots around the globe. The resulting pandemic killed 150 million people within a year as officials struggled to contain the social and economic chaos until a vaccine could be made.

"What people don't think about very often is the potential for an engineered organism to become an epidemic or even a pandemic. One of the goals of this exercise was to show that an engineered organism could be the cause of something that we are not really preparing for," says Dr. Tom Inglesby, director of the Johns Hopkins center. "What we wanted to show in the exercise was that there are different ways of getting to a pandemic. And we need to be prepared for all of them."

Much of the public health response to an engineered outbreak would be the same as to a natural outbreak, the exercise showed. That means a possible line of defense is beefing up public health infrastructure such as disease surveillance.

And, as the new report notes, the same synthetic biology tools that could be used to harm could also be used to fight this threat, by allowing the rapid creation of better medicines, vaccines, and diagnostics.

Pamela Silver, a synthetic biologist at Harvard who was not on the committee but reviewed its report, said that the assessment is "timely, given that there's a lot of attention being paid to genetic engineering because of CRISPR," the new tool that has made it much easier to edit genes.

She does worry, though, that because this report ranked potential threats, "somebody might say 'oh, here are the three things we have to worry about the most,' and then ignore the others."

And this assessment was made based on today's technology, she says, but it's clear that biology changes rapidly and is full of surprises. "So what's the next CRISPR? What's the next big thing?" Silver asks. "We need to anticipate, as well. Biology is a rapidly moving field and we need to stay on top of that."

She says she just recently was looking at a preprint of a scientific paper about engineering bacteria, "and I noticed that it was from high school students. That's just amazing to me."

Tim, David, and Tom - thanks for flagging and posting the article from Forbes.

This could be the single most important policy initiative President Trump undertakes, given the potential consequences of a devastating pandemic. It does not require a great deal of additional federal funding, but it does need some sort of mechanism to coordinate all the federal players. The most important player at present is the Assistant Secretary of Health and Human Services for Preparedness & Response, who works with the Centers for Disease Control and others to maintain adequate stockpiles of medical countermeasures.

U.S. Sen. Richard Burr (R-NC), who crafted and sponsored the nation’s original law protecting public health during man-made and natural disasters, and then took the lead on the law’s subsequent restructuring, again has commanded the next phase of reauthorizing the … Read More »

The top White House official responsible for leading the U.S. response in the event of a deadly pandemic has left the administration, and the global health security team he oversaw has been disbanded under a reorganization by national security adviser John Bolton.

The abrupt departure of Rear Adm. Timothy Ziemer from the National Security Council means no senior administration official is now focused solely on global health security. Ziemer’s departure, along with the breakup of his team, comes at a time when many experts say the country is already underprepared for the increasing risks of a pandemic or bioterrorism attack.

Ziemer’s last day was Tuesday, the same day a new Ebola outbreak was declared in Congo. He is not being replaced.

Pandemic preparedness and global health security are issues that require government-wide responses, experts say, as well as the leadership of a high-ranking official within the White House who is assigned only this role.

“Health security is very fragmented, with many different agencies,” said J. Stephen Morrison, senior vice president at the Center for Strategic and International Studies. “It means coordination and direction from the White House is terribly important. ”

It is widely recognized that American farmers and ranchers make a major contribution to the U.S. economy by providing a safe and reliable food supply, which promotes energy security, job growth, and economic development. The U.S. Department of Agriculture (USDA) reports that in 2015, agriculture, food, and allied industries contributed more than $992 billion to the gross domestic product (GDP)—representing a 5.5 percent share of the total [1]. America’s farms alone contributed $136.7 billion in GDP [1]. Furthermore, the USDA indicates that the U.S. food and beverage manufacturing sectors together employ more than 1 percent (1.5 million people) of all non-farm employment [1]. An attack on American agricultural assets would threaten the security, safety, and availability of U.S. food supplies and cause significant economic damage to the U.S....

Since its inception over a decade ago, the Department of Homeland Security has had authority over the $1.25 billion National Bio and Agro-defense Facility, or NBAF, under construction on the campus of Kansas State University.

The 2019 federal budget released this week proposes transferring authority over the facility to the U.S. Department of Agriculture. The transfer wouldn’t happen until the facility operational, scheduled for 2022. But officials say the USDA will work closely with DHS long before the lab opens.

“USDA would begin (staffing) up the operations of NBAF by learning how to operate the facility during the commissioning process, purchasing equipment and hiring employees,” DHS spokesman John Verrico said in an email.

NBAF is to replace the aging Plum Island Animal Disease Center in the Long Island Sound. For over half a century, the lab was operated by USDA for the study of foreign animal diseases. It was the only place in the country with a large-animal bio-containment facility capable of studying live foot-and-mouth disease virus, which is highly contagious among cattle and sheep. The labs at NBAF will expand research on foot-and-mouth and have the capacity to do experiments on large numbers of livestock at one time.

In 2002, with the passage of the Homeland Security Act, authority of the lab at Plum Island was transferred to the newly- formed DHS.

Lawmakers and some officials are saying it’s too early to know the impact of placing the Plum Island's replacement back under the oversight of USDA.

U.S. Rep. Roger Marshall, whose district includes NBAF, sits on the House Agriculture and Science and Technology committees. He said he’s focused on making sure the facility is built on schedule and has adequate funding.

“While the proposal to move operational control to USDA is new, we have always expected USDA to play a major role in the research underway at the facility,” Marshall said in an email.

But one scientist who’s been intimately involved with biosecurity research says it’s a mistake to move the Level 4 bio-containment lab away from Homeland Security.

Daniel Gerstein oversaw operations at Plum Island while it was under DHS. He says Homeland Security and agriculture officials had a strong working relationship — even developing the first licensed foot-and-mouth vaccine.

But prioritizing homeland security in animal disease research may be more important today than ever, he says.

“If you had some sort of deliberate attack, you’d certainly want to have your Department of Homeland Security involved.”

Recent reporting suggests that the Trump administration is preparing to downsize the Centers for Disease Control’s (CDC) global epidemic prevention activities in 39 of 49 countries starting in 2019 when funding first authorized by Congress in 2014 expires. Such a move is potentially dangerous and could place the U.S. at significant risk.

When the funding for the CDC’s epidemic prevention activities around the world expires, the emphasis would be placed on preventing disease in 10 priority countries. This would mean that work would be scaled back or perhaps even halted in key nations such as China, Pakistan, Haiti, Rwanda and Congo, which have been hot spots for emerging infectious diseases such as SARS, Foot and Mouth Disease, Cholera and Ebola.

The proposed cutbacks would likely result in the elimination of some CDC-funded epidemic prevention centers in the 39 countries which serve as the front line in disease monitoring and prevention and provide education and support for the development of partner disease surveillance and treatment capacity.

The notion of a shared responsibility to prevent global public health emergencies caused by disease epidemics is hardly new. The history goes back to the 1851 International Sanitary Conference in Paris that followed the cholera epidemics in Europe between 1830 and 1847.

The adoption of the World Health Organization’s International Sanitary Regulations in 1951, which were replaced by and renamed the International Health Regulations in 1969, reinforced the idea that nations should have adequate disease surveillance systems in place.

More recently, the Obama administration led the development of the 2014 multinational Global Health Security Agenda to prevent “the global spread of infectious-disease epidemics.” The failure to renew funding for global epidemic prevention could represent a reversal of key trends regarding cooperation in disease surveillance.

At first glance, the benefits of these initiatives may seem confined to the partner nations where disease monitoring and preparedness and response programs are based. In fact, the programs provide sentinels for a broader global disease monitoring system of which the U.S. is a significant beneficiary.

Over the past decade, many have come to recognize public health as a national security issue worthy of funding levels that promote and support global health preparedness and response systems. Some disease events — either naturally occurring outbreaks such as influenza or intentional use of pathogens in biological warfare or bioterrorism — have serious national security implications.

Having international and partner systems that promote information sharing in real-time, pre-incident preparedness and response capabilities are important components of public health efforts in the U.S.

It is also noteworthy that this downsizing of global epidemic prevention activities seems to contradict the recent National Security Strategy released several weeks ago that lists as one of the priorities to “detect and contain biothreats at their source.”

The international efforts during the 2013-2016 Ebola pandemic, the 2015-2016 Zika outbreak and now this year’s seasonal influenza (which has been the most virulent strain in 10 years), demonstrate the need to maintain and enhance these key disease surveillance activities.

The ability to understand the progression of disease requires global disease surveillance networks that include competent partners with the necessary capacity. Unfortunately, many of these nations lack the resources — including funding, knowledge and facilities — and therefore must depend on support for development of their programs.

These recent disease outbreaks also demonstrate a lack of preparedness for these events in the U.S. shortfalls include inadequate understanding of the progression of the diseases, inability to provide adequate guidance to the public, and lack of medical countermeasures and treatment guidance to name a few.

In the U.S., there were only a couple of Ebola patients, but the knowledge derived from sharing information about the over 25,000 others who were infected with the virus in Africa left the U.S. better prepared.

Reconsidering the current course, taking into account the additional risk burden that would be created by scaling back CDC epidemic prevention activities, could lead to new funding for the programs.

Without renewed funding, the long-term outlook could include weakened global disease surveillance and response systems, less capable partner nations and an increased likelihood of global disease outbreaks that would undoubtedly threaten the U.S.

Daniel M. Gerstein works at the nonprofit, nonpartisan RAND Corporation and is an adjunct professor at American University. He was the undersecretary (acting) and deputy undersecretary in the Science and Technology Directorate of the Department of Homeland Security from 2011-2014.

Dr. Kimothy Smith announced the Company's successful detection of the influenza virus on its FireflyDX prototype system and its publication of a white paper.

AUSTIN, Texas, Jan. 31, 2018 (GLOBE NEWSWIRE) — SmallCapVoice.com, Inc. today announced it conducted a new audio interview with PositiveID Corporation (“PositiveID” or the “Company”) (OTC:PSID), a life sciences company focused on detection and diagnostics, regarding the Company’s successful detection of the influenza virus on its FireflyDX real-time polymerase chain reaction (PCR) breadboard prototype system (“prototype system”). The interview can be heard at https://smallcapvoice.com/blog/1-30-18-smallcapvoice-interview-with-positiveid-corporation-psid.

In the interview, Dr. Kimothy Smith, Chief Science Officer of PositiveID and its ExcitePCR Corporation subsidiary, announced the Company’s successful detection of the influenza virus on its FireflyDX prototype system and its publication of a white paper. Smith described the limitations of current rapid influenza detection tests, and discussed how FireflyDX could enable correct diagnosis at the point of care for smart treatment decisions. PositiveID and ExcitePCR are developing FireflyDX, in both portable and handheld forms, to enable fast, accurate diagnosis at the point of care or point of need (POC/PON).

The FireflyDX family of products, currently under development, is designed to provide accurate, rapid pathogen detection using real-time PCR in less than 30 minutes, with minimally trained personnel and at a lower cost than existing systems. Current solutions for accurately identifying potential pathogens and bio-threats, especially at the POC/PON, can sometimes take as long as several hours to several days to provide results, dramatically delaying what is often life-saving treatment. Five different flu virus assays (Type A; Type B; H3N3; H7N1; and, H5N1) were tested on the FireflyDX prototype system in the lab.

DELRAY BEACH, Fla., Jan. 22, 2018 (GLOBE NEWSWIRE) -- PositiveID Corporation (OTC:PSID), a life sciences company focused on detection and diagnostics, and its ExcitePCR Corporation subsidiary, announced today that Lawrence Livermore National Laboratory has completed an analysis and report of the FireflyDX real-time polymerase chain reaction (PCR) pathogen detection prototype. PositiveID and ExcitePCR have published the report on their websites.

The FireflyDX™ prototype system is designed to be a portable, fully automated, lab quality, real-time device able to process samples and detect pathogens at the point of care/point of need (POC/PON), faster and less expensively than existing devices.

“We are extremely proud to demonstrate the progress we’ve made in the development of FireflyDX, which, we believe, better positions ExcitePCR for the appropriate funding to move FireflyDX to its next stage and closer to commercialization,” stated Lyle L. Probst, CEO and President of ExcitePCR.

“The opportunity to show the FireflyDX prototype system in action and present data that validates our detection capabilities and demonstrates our ability to compete against industry-standard, lab-based equipment was a high point for the ExcitePCR team,” said Dr. Kimothy Smith, Chief Science Officer of ExcitePCR.

FireflyDX's applications include the near real-time detection of pathogenic organisms in verticle markets addressing human clinical applications, infectious diseases, and hospital acquired infections; agricultural and food screening in both domestic sectors and developing countries; and detection of biological agents associated with weapons of mass destruction.

The report, which has been partially redacted due to the proprietary nature of certain content, was prepared under agreement between PositiveID and Lawrence Livermore National Laboratory.

We have a responsibility to ensure that research with infectious agents is conducted responsibly, and that we consider the potential biosafety and biosecurity risks associated with such research. I am confident that the thoughtful review process laid out by the HHS P3CO Framework will help to facilitate the safe, secure, and responsible conduct of this type of research in a manner that maximizes the benefits to public health.

WASHINGTON (DTN) -- The U.S. is woefully unprepared to cope with outbreaks of emerging livestock or crop pathogens and pests, whether those outbreaks are caused intentionally or otherwise, experts told the Senate Agriculture Committee on Wednesday.

Agricultural security risks have become a major concern for Senate Agriculture Committee Chairman Pat Roberts, R-Kan., but the chairman acknowledged that talking about a possible attack on agriculture or food production is a hard conversation.

"This is a difficult issue because if you come out and say what's on your mind, you scare the dickens out of people," Roberts said.

Roberts said when he first became interested in the issue nearly two decades ago through his work on a Senate subcommittee on emerging threats, he kept telling farm organizations, veterinarians and others about the need to step up and examine the risk. The response, he said, was people asked him to quit talking about agro-security risks because it could affect commodity prices.

"Well, we should look out. I can promise you every member of this committee is aware of this threat," Roberts said.

Experts on Wednesday pointed to a recent report in the Washington Post that North Korean dictator Kim Jung Un is building up his country's biological infrastructure, based on an intelligence report. North Korea's new efforts in biological warfare have alarmed U.S. analysts, the Post reported.

Agrodefense is a broad and complex mission space. Collectively, experts testified Wednesday that the country faces a shortage of livestock vaccines, lack of coordination among federal agencies, lack of intelligence capability, lack of funding and overall lack of awareness.

"Other than that, we're in pretty good shape," Roberts commented.

Former Connecticut Sen. Joe Lieberman co-chairs a blue-ribbon panel on biodefense that released a report in October specifically looking at animal agriculture. Lieberman noted that, early in the Afghanistan war, a Navy Seal team found chemical formulas of 16 deadly pathogens in a cave. Six of those pathogens could target livestock, and four could attack crops.

"Agro-defense is a real national security problem," Lieberman said.

Speaking specifically of Kim Jung Un's desires, Lieberman said an attack on agriculture could do damage to the country and inject fear in people, and such an attack would be relatively easy. The problem, he said, is that such a concept largely flies under the radar.

"How do you get attention for it? Unfortunately, it's very hard," Lieberman said.

Lieberman and others noted the U.S. has already seen some devastating livestock diseases in recent years that came into the country accidentally or through the wild. In 2015, for instance, avian influenza led to the deaths of nearly 50 million poultry and raised the price of eggs.

"The most visible, tangible example we've had was the avian flu outbreak, which not only cost the birds, but cost the economy an estimated over $3 billion," Lieberman said.

While avian influenza is largely spread by wild birds, Lieberman cited the risk and fear that avian influenza would spread from wild birds to people.

Pork producers also have been hit with a foreign animal disease. In 2013, porcine epidemic diarrhea virus (PEDv) hit the U.S. pork industry, killing more than 8 million pigs and causing major financial losses for some pork producers. Myers, in written testimony, said it's suspected PEDv came into the U.S. in feed products from China, but that has not been confirmed.

Retired Gen. Richard Myers, now president of Kansas State University, said the intelligence community has a strong recognition about the importance of food security to global stability. Myers noted 15 crops account for 90% of global food intake, with corn, wheat and rice accounting for fully two-thirds of food intake. If wheat, rice or corn were targeted by bioterrorists, or if a natural outbreak occurs, "We're going to be in big trouble," Myers said.

Kansas State University is now home to the National Bio-Agrodefense Facility, which is being constructed. But Myers said there is a funding gap for research and a real weakness in the vaccine stockpile on hand to deal with a major animal-disease outbreak.

Myers also said the U.S. doesn't have the right number of experts with appropriate clearances to deal with such possible outbreaks -- whether they are intentional or not.

The National Veterinary Stockpile receives less than $5 million in funding. Lieberman said that's a risk that would quickly become apparent if a quick-spreading disease hit livestock.

"When there is an outbreak, people are going to be screaming for vaccines or other countermeasures, and there is nothing there right now," Lieberman said.

R.D. Meckes, state veterinarian of North Carolina and a former Department of Homeland Security expert on agrodefense issues, reiterated the need for a more robust national veterinary stockpile of vaccines. A Foot and Mouth Disease (FMD) outbreak could cost the U.S. economy as much as $200 billion over 10 years, he said.

"An FMD outbreak in a livestock-dense area of the U.S. cannot be controlled without immediate access to millions of doses of FMD vaccine," he said.

The National Cattlemen's Beef Association and National Pork Producers Council have been requesting the House and Senate Agriculture Committees fund a more robust vaccine bank in the next farm bill that would set aside large amounts of vaccines for diseases such as FMD. Such a vaccine bank could be costly, but would be preventive medicine against an outbreak that could cost billions to agriculture if FMD were to show up in the U.S.

USDA is close to issuing a rule on reportable animal diseases, which Lieberman said would hopefully clarify the responsibility of the private sector to report those outbreaks.

Myers had several recommendations to boost biodefense readiness, including more research and funding related to diseases. Further, more outreach is needed to industry to help with research. Land-grant universities also should play a larger role in helping deal with agrodefense, he said.

Livestock and plant experts are telling the Senate Ag Committee the country is not prepared for some of the diseases -- introduced intentionally or not -- that could spread rapidly and devastate U.S. agriculture.

Sen. Debbie Stabenow, D-Mich., ranking member of the Agriculture Committee, pointed to scares in Michigan, such as the cherry growers getting hit by a small pest called the spotted wing drosophila, which Stabenow said "has become a cherry grower's worst nightmare."

Another pressure leading to the spread of pathogens is climate change. "We're seeing pathogens in Michigan that used to not handle the winter, but now can survive over winter months," said Raymond Hammerschmidt a professor of plant, soil and microbial sciences at Michigan State University.

Agricultural genetic technologies typically achieve their agronomic aims by introducing laboratory-generated modifications into target species' chromosomes. However, the speed and flexibility of this approach are limited, because modified chromosomes must be vertically inherited from one generation to the next. In an effort to remove this limitation, an ongoing research program funded by the U.S. Defense Advanced Research Projects Agency (DARPA) aims to disperse infectious genetically modified viruses that have been engineered to edit crop chromosomes directly in fields. This is genetic engineering through horizontal transfer, as opposed to vertical inheritance. The regulatory, biological, economic, and societal implications of dispersing such horizontal environmental genetic alteration agents (HEGAAs) into ecosystems are profound. Further, this program stipulates that the means of delivery of these viral HEGAAs into the environment should be insect-based dispersion ([ 1 ][1]). In the context of the stated aims of the DARPA program, it is our opinion that the knowledge to be gained from this program appears very limited in its capacity to enhance U.S. agriculture or respond to national emergencies (in either the short or long term). Furthermore, there has been an absence of adequate discussion regarding the major practical and regulatory impediments toward realizing the projected agricultural benefits. As a result, the program may be widely perceived as an effort to develop biological agents for hostile purposes and their means of delivery, which—if true—would constitute a breach of the Biological Weapons Convention (BWC).

NATIONAL BIODEFENSE STRATEGY: President Donald J. Trump is directing the implementation of a National Biodefense Strategy to more effectively prepare for and combat biological threats.

Strengthening our biodefense will better protect the American people, our homeland, and the welfare of our citizens.

President Trump’s National Biodefense Strategy will lead to a more efficient, coordinated, and accountable biodefense enterprise.

The biodefense National Security Presidential Memorandum names the Secretary of Health and Human Services, Alex Azar, as the Federal lead for biodefense and establishes a Cabinet-level Biodefense Steering Committee.

The National Security Presidential Memorandum will create a new mechanism for coordinating the full range of biodefense activities and budget resources across the Government.

Until now, agencies have had disparate programs that were not centrally coordinated.

The danger of a chemical or biological attack against the U.S. homeland is growing. In the case of chemical threats, thousands of sites around the world manufacture precursors that could be used to fashion weaponized toxins such as nerve gas. North Korea and Syria apparently have done so. In the case of biological threats, the tools and skills needed to engineer virulent pathogens are increasingly available to extremists. Either type of threat could kill vast numbers of Americans.

Against that backdrop, the Lexington Institute on June 18 released a concise report describing the nature of the threat, detailing why the danger of an attack is growing, and delineating what steps the federal government should take to bolster preparedness. In brief, the findings of the report are as follows:

The federal government spends little on preparing for chemical or biological attacks against the U.S. homeland, even though the risk of such attacks is rising.Biological threats such as bacteria and viruses potentially can kill millions; recent advances in the life sciences now enable researchers to fashion lethal pathogens in laboratories.Skills to inexpensively synthesize pathogens are identical to those used in other areas of biological research, and have become increasingly available to extremists through global commerce.The precursors of lethal chemical weapons such as nerve agents are manufactured at thousands of sites around the world, and have been weaponized by countries such as Syria and North Korea.Treaties banning chemical and biological weapons have been signed by many countries, but it is difficult to control the spread of relevant technologies and there are no agreed standards on sharing information.Researchers have recently synthesized a virus similar to that causing smallpox — the most lethal virus in history — and published information on how they did it in a public forum.Federal preparations for detecting and responding to chemical or biological attacks are under-funded and fragmented between many agencies and congressional committees.New technologies have been developed for countering the threat of chem-bio attack, but the government needs a central coordinating mechanism to assure those technologies are deployed in timely fashion.Some of the new technologies cut the cost of identifying threatening agents to a small fraction of that required by traditional methods and greatly reduce the time needed, potentially bolstering chem-bio defense efforts. The government should strengthen homeland defenses against chemical and biological threats, including the accidental release of pathogens from laboratories — a process that requires relatively little additional money but more leadership.

Weapons of mass destruction come, but they rarely go. Complex and difficult to produce, in some cases impossible to eliminate, they are intentionally developed but frequently without plans or opportunities for use. The last major review of the military-industrial-scientific complex of weapons of mass destruction was conducted in the late 1980s. President Reagan’s words echo through history: “trust but verify.”The Nunn-Lugar Act conceived in 1986 passed into law in 1991. Senators Sam Nunn and Richard Lugar conceived and legislated a cooperative threat reduction program based upon the idea of dismantling—as in taking apart physical assets, such as nuclear bombs. The purpose was to reduce the volume of the world’s nuclear, biologic and chemical weapons in the aftermath of the Soviet Union’s collapse. Dismantling was an appropriate effort for the time, but it is woefully out of date today. A different genie is out of the gene pool.The first Nunn-Lugar produced programs that sought to address chemical and biological weapons of mass destruction were miniscule in comparison to the taming of the nuclear arsenal. A few biosafety labs were developed in the former Soviet bloc, and numerous scientists were brought to the United States.The Biological and Chemical Weapons Conventions have been upgraded numerous times since 1991. The International Health Regulations were overhauled and adopted just in time for the 2009 H1N1 outbreak to test the ability to report on suspicion of cross-border spread.New techniques for disposing of nuclear and chemical arsenals have been successful in cleaning old munitions dumps. Yet, the main quantifiable change and result was in reducing and making safe the Soviet nuclear arsenal targeted at Europe and the United States. It was so successful the Bulletin of Atomic Scientists changed their Doomsday Clock back to 17 minutes to midnight.Today, however, the Doomsday Clock is at 2 minutes to midnight, the main threats not being nuclear but instead chemical and biological. Consider that chemical weapons have been used routinely in the Syrian civil war, which expands other nations’ understanding of how to deploy their violence.The talks of denuclearizing North Korea mean today we may have the momentum to develop a new Nunn-Lugar. This could, should and must be as focused on the chemical and biological threats as much or more than the nuclear threat....

Abstract

Some public health crises and disasters represent threats to national security. In 2010 and 2011, Haiti experienced a cholera disaster surpassing all others in the world following a catastrophic earthquake. A novel integrated intelligence system, the Haiti Epidemic Advisory System (HEAS), provided critical information indicating the United Nations was the accidental source of the cholera disaster. This report reviews the operational context of the HEAS in relation to traditional public health surveillance and the role of intelligence in the determination of biological threat attribution.

A SECRET LOCATION OUTSIDE WASHINGTON, D.C. — From the outside, it looks like an ordinary commercial warehouse, only much bigger, about the size of two super Walmarts. Inside it’s dark except when motion sensors are triggered. When the lights come on, hundreds of thousands of shrink-wrapped boxes of medicines emerge from the gloom, stacked on shelves nearly five stories high.

This is quite a different kind of warehouse. It and several others across the country are part of the $7 billion Strategic National Stockpile, a government repository of drugs and supplies ready for deployment in a bioterrorism or nuclear attack, or against an infectious disease outbreak — of either a known pathogen or some unknown threat with pandemic potential, which global health officials dub “Disease X” — or other major public health emergency. There are antibiotics, including the powerful medication Ciprofloxacin, vaccines for smallpox and anthrax and antivirals for a deadly influenza pandemic.

The need for biodefense has become more clear in the wake of outbreaks of Ebola in West Africa, Zika in the Americas, devastating wildfires and hurricanes, and the poisonings of the North Korean leader's half brother in Malaysia and former Russian spies in England with nerve and radiological agents. Last year, the federal government added three new chemicals to its list of high-priority threats, including chlorine and blister agents, such as mustard gas, that have been used in deadly chemical weapons attacks in Syria. On Monday, officials announced plans to add more anthrax antitoxin.

The federal omnibus spending bill unveiled Wednesday night includes full funding for a Fort Detrick laboratory that is one of its kind in the country.

The bill fully restores funding for federal laboratories the Trump administration proposed to close, including continued operational costs of $44.3 million for the National Biodefense Analysis and Countermeasures Center (NBACC).

The Fort Detrick facility includes two high-level laboratories that handle federal select agents and toxins, including the Ebola virus, ricin and avian influenza.

One component of NBACC is the National Bioforensic Analysis Center, the only laboratory in the country that processes evidence for the FBI in criminal investigations involving biological threats such as ricin and anthrax. Since 2004, the laboratory has processed more than 14,000 pieces of criminal evidence.

The other laboratory at Detrick is the National Biological Threat Characterization Center (NBTCC), which aims to understand the science of biological threats.

News of the funding bill came after months of uncertainty for NBACC, a federally contracted laboratory operated by the Battelle National Biodefense Institute (BNBI). The lab lost 20 staff members after a closure notification was issued in May 2017, according to a previous report in The Frederick News-Post.

The nearly $44 million in renewed funding would allow NBACC to remain fully operational, according to communications director Brian Gaudet. The lab has been an important component of national biodefense measures since 2006, when construction began in the wake of the 2001 anthrax attacks through letters sent in the U.S. mail.

“Obviously, we’re thrilled by the omnibus [measure] and are very happy to see that funding has been restored in the House bill,” Gaudet said. “Obviously, stability is important in any business, but especially in a laboratory, where you need to be able to attract and retain the top talent in the field.”

The 2,232-page funding bill also outlines a change in the funding structure for the laboratories, splitting the budgetary responsibilities between the Department of Homeland Security and the FBI.

“This cost-sharing arrangement would result in a more efficient operational model and ensure this national capability remains available to help defend the United States against bioterrorism threats,” according to an explanatory statement accompanying the bill.

Van Hollen emphasized the importance of the lab shortly after the omnibus spending bill was announced.

“There is no question that this legislation represents compromise, but it includes several Maryland priorities,” Van Hollen (D) said in an emailed statement on Wednesday night. “A key victory that our Maryland team fought hard for is funding for the National Biodefense Analysis and Countermeasures Center on Fort Detrick. The work done at this lab is essential to protecting our country from biological attacks, and I will continue to advocate for this crucial tool for our national security.”

The bill also restores funding for the Chemical Security Analysis Center, another Department of Homeland Security laboratory, at Aberdeen Proving Ground.

Lawmakers must take up and approve the omnibus bill, which funds the government through September, by Friday at 11:59 p.m. to avoid a government shutdown. The measure passed the House of Representatives on Thursday and was awaiting a vote in the Senate. Timing of the Senate vote was uncertain Thursday evening.

This insightful commentary was authored by Dr. James M. Wilson and Dr. Kimothy L. Smith regarding the National Biosurveillance Center (NBIC). Timely sharing of information regarding biothreats is critical for federal, state, and local agencies to understand the threats and respond to bioterrorism events quickly and effectively. The NBIC, housed in the Department of Homeland Security, has been the primary entity responsible for facilitating bio threat information sharing across the federal government. The future of the NBIC is now in jeopardy, while bioterrorism attacks in the United States remains a real threat. Should the NBIC continue operations? Our resident biodefense experts, Jim and Kimothy will walk you through the arguments.

Maureen

The Department of Homeland Security’s National Biosurveillance Integration Center: Cancel the Program or Call For an Overhaul?

James M Wilson V, MD FAAP and Kimothy L. Smith, DVM PhD

The Department of Homeland Security’s National Biosurveillance Integration Center (NBIC) was created in the wake of the 2001 Amerithrax attacks, 9/11 attacks on the World Trade Center and the Pentagon, Severe Acute Respiratory Syndrome (SARS), and global emergence of influenza A/H5N1. NBIC’s creation also followed the National Intelligence Council’s 2000 Estimate that highlighted infectious disease as a national security issue for the first time in U.S. history. The Trump Administration’s National Security Strategy of the United States of America, released in December 2017, emphasized biological threats as a leading national security concern.

The original premise in the National Intelligence Council’s 2000 Estimate- that biothreats may be naturally, accidentally, or intentionally caused- was a novel concept at the time, where the majority of the traditionally minded national security professionals focused on intentional acts. The classic definition of intelligence was the standard:

Intelligence is the collecting and processing of that information about foreign countries and their agents which is needed by a government for its foreign policy and for national security, the conduct of non-attributable activities abroad to facilitate the implementation of foreign policy, and the protection of both process and product, as well as persons and organizations concerned with these, against unauthorized disclosure.[1]

Intelligence related to biothreats was viewed as a difficult-to-define non-traditional exception to this definition. There was a bias towards intelligence and detection technologies focused on human actors’ intent to weaponize biological agents. However, history had shown that naturally occurring biothreats such as the threat of a 1918-like influenza pandemic could catch the United States by surprise and result in more loss of life than all of the modern examples of biological weapon deployments combined. The 2009 H1N1 influenza pandemic, Middle East Respiratory Syndrome (MERS) crisis, West Africa Ebola disaster, and Zika crisis affirmed this point as well as reveal serious issues with timely warning and the need for accurate and balanced threat assessments. The United States continues to exhibit delayed recognition and warning of these difficult-to-predict biothreats and is highly reactive in its response. Worse, these shortfalls are continually broadcast publicly to those who may seek to do us harm. In summary, our nation still does not have an effective warning system for biothreats associated with national security implications.

The core issue that has always faced NBIC is the acquisition of enough information to generate a warning message early enough in the evolution of a biothreat to enable more proactive response and hence, promote local community resilience. Biothreats often appear without diagnostic clarity: we do not know what pathogen is involved, whether we are dealing with a previously unknown pathogen, or whether it is a well-known pathogen that has mutated. Even more concerning, attribution is often not known until weeks, months, or years later. Time-sensitive resolution of uncertainty is a critical prerequisite for generating a well-considered response. Unfortunately, these threats are often associated with tremendous delays in recognition and bureaucratic hesitation to discuss uncertainty with the public. The result is unbalanced threat assessments and highly reactive response. Our local responders and citizens are the ones who receive the brunt of this failure.

As far as the United States is concerned, the feared coming apocalypse of Ebola, biological weapon, or accident of biotechnology “run amuck” has not been seen. One might surmise that either we are overblowing this threat, simply lucky, or something in-between. What we have seen are ongoing examples of socio-economic disruption and periodic distraction of our country’s top officials when these crises and disasters have appeared. The issue at-hand is having an appropriate system of assessing risk and communicating that risk in a well-considered, balanced manner without the need to generate hype.

We are concerned to hear recently that NBIC is being considered for programmatic cancellation by the newly formed Combatting Weapons of Mass Destruction Directorate of DHS. We are even more concerned given we have, for several years now beginning with the Obama Administration, witnessed a dramatic scaling back of biointelligence assets and capabilities that leave our nation without the technical advantage we once had. We estimate we are now 20 years behind where we were at the start of the first term of Obama’s presidency. At worse, we have provided (and continue to provide) robust demonstration to our adversaries that we are unorganized, undecided, and woefully ill-prepared.

There is little disagreement the NBIC program has been troubled from its initiation[2],[3], however, our nation’s continued neglect of this intelligence space will not simply wish it away. The gaps in intelligence continue to widen, and the support we are supposed to provide our already-strained healthcare, veterinary, and crop infrastructure is simply not adequate. One decision is certainly to cancel the program and perhaps attempt a reboot under another agency. However, it is fair to say it is unlikely we will see a reboot attempt until our nation experiences a direct hit from one of these national security-level biothreats.

A more productive, alternative path would be to convene a transparent public hearing on NBIC before Congress, where all of the prior Directors and Chiefs of Operations present their perspectives regarding the challenges and most importantly, potential solutions that will truly enable a full realization of the mission we had all envisioned for NBIC and our country. The program requires a complete review of its current mission and vision, operations, product output, and relationships with its partner agencies. The review must include an unbiased view of the current “value-add” of NBIC’s products and whether those products are addressing this country’s critical need for an effective warning system for biothreats. NBIC requires an Advisory Board and guidance from experienced operations personnel. It also requires strong, results-oriented action from DHS’ senior leadership, the Homeland Security Council, accompanied by White House-backed coordination (as highlighted by the Biodefense Blue Ribbon Panel and now by President Trump’s proposed National Security Strategy).

Without these constructive changes, the United States will continue to be surprised by biological threats and continue to be reactive in response. And someday our country may see our luck run out.

For additional information on this topic contact Dr. James Wilson (Email: jamesmwilson@unr.edu)

Dr. Wilson was the first operations chief of the Department of Homeland Security’s National Biosurveillance Integration Center and worked with the Intelligence Community during the birth of formal health security intelligence in the mid-2000s. Dr. Wilson led the private intelligence teams that provided warning of the 2009 H1N1 influenza pandemic, discovery of the United Nations as the source of the 2010 cholera disaster in Haiti, and several investigations of alleged and confirmed biological weapon deployments. He is currently the Director of the Nevada Medical Intelligence Center in the School of Community Health Sciences and a practicing pediatrician in the Department of Pediatrics at the University of Nevada, Reno

Prior to moving to the private sector in 2008, Dr. Smith was the Senior Advisor for International Biodefense for the Department of Homeland Security (DHS), Office of Health Affairs. While in this position he served as a detailee to the Office of International Health & Biodefense of the U.S. State Department. In his tenure at State, Dr. Smith served as a subject matter expert working with international partners to promote coordinated biodefense and emergency response strategies and to open dialogues on food and agricultural security and safety. Dr. Smith’s responsibilities at DHS included serving as the Acting Director of the National Biosurveillance Integration Center and in 2005, Dr. Smith was named as the first Chief Veterinarian for DHS and Chief Scientist for the Office of Health Affairs.He is currently Executive Vice President and Chief Science Officer for Excite-PCR, a biotechnology company based in Pleasanton, California.

Dr. Kimothy Smith discusses importance of point of care/point of need detection during flu season.

DELRAY BEACH, Fla., Feb. 05, 2018 (GLOBE NEWSWIRE) -- PositiveID Corporation (the “Company”) (OTC:PSID), a life sciences company focused on detection and diagnostics, and its ExcitePCR subsidiary announced today that Chief Science Officer, Dr. Kimothy Smith, discussed the Company’s successful detection of influenza virus on its FireflyDX real-time polymerase chain reaction (“PCR”) breadboard prototype system (“prototype system”) in a new interview with CEOLIVE.TV. The interview can be viewed here.

In the interview, Smith described the Company’s successful detection of several types of the influenza virus on its FireflyDX prototype system and discussed the importance of point-of-need detection for flu and other pathogens. Smith also detailed the ease of use of the Company’s FireflyDX prototype system and discussed how FireflyDX could enable faster, more accurate diagnosis at the point of care or point of need (“POC/PON”). Five different flu virus assays (Type A; Type B; H3N3; H7N1; and, H5N1) were tested on the FireflyDX prototype system in the lab.

PositiveID and ExcitePCR are developing the FireflyDX family of products in both portable and handheld forms, to provide accurate, rapid pathogen detection using real-time PCR in less than 30 minutes, with minimally trained personnel and at a lower cost than existing systems. Current solutions for accurately identifying potential pathogens and bio-threats, especially at the POC/PON, can sometimes take as long as several hours to several days to provide results, dramatically delaying what is often life-saving treatment or quarantine measures.

A stratified biodefense hospital system would provide the United States with a protective shield in the event the country experiences a man-made or natural biological catastrophe, panelists told members of the Blue Ribbon Study Panel on Biodefense. The suggestion is … Read More »

DELRAY BEACH, Fla., Jan. 03, 2018 (GLOBE NEWSWIRE) -- PositiveID Corporation (“PositiveID” or “Company”) (OTC:PSID), a life sciences company focused on detection and diagnostics, announced today that its ExcitePCR Corporation subsidiary, will present and exhibit at the Seed Central Tech Showcase on Thursday, January 11, 2018, at the University of California, Davis Conference Center. Kimothy L. Smith, DVM PhD, EVP and Chief Science Officer of ExcitePCR, will discuss how the company’s FireflyDX technology can be used for agricultural screening and food safety testing.

PositiveID previously announced its FireflyDX polymerase chain reaction (“PCR”) breadboard prototype pathogen detection system (“prototype system”) successfully detected genetically modified organisms (“GMOs”), specifically corn and soybeans, during a pilot study with seqID inc. The pilot study evaluated the use of FireflyDX to detect genetically modified corn and soybeans at seaports where corn and soybeans are being shipped to countries that limit the percentage of GMOs in the shipment that may be imported. During the lab-based testing, the FireflyDX prototype system detected GMOs in corn and soybeans at amounts below 1%. This level of detection could be useful for stopping shipments containing even very low quantities of GMOs to countries that prohibit them.

PositiveID, through its ExcitePCR Corporation subsidiary, is developing the FireflyDX family of products, automated pathogen detection systems for rapid diagnostics at the point-of-care/point-of-need (“POC/PON”). The FireflyDX family products, consisting of the FireflyDX-Portable™ and the FireflyDX-Handheld™, are designed to be lab quality, real-time devices able to detect pathogens faster and less expensively than existing systems. FireflyDX’s applications include POC/PON detection of pathogenic organisms; agricultural and food screening in both domestic sectors and developing countries; and detection of biological agents associated with weapons of mass destruction.

PLEASANTON, CALIF. (PRWEB) DECEMBER 14, 2017For the first time, ExcitePCR has been recognized as a “major player” in the Point-of-Care/Point-of-Need (POC/PON) healthcare diagnostics marketplace.According to Questale (a market research firm based in San Francisco, California), ExcitePCR is one of fewer than 20 companies named in its recently published research report under the category of Infectious Diseases Testing. The Questale report — Global POC Molecular Diagnostics Market Size, Status and Forecast 2022 — was published November 21, 2017.“It’s a real honor for ExcitePCR to be included in Questale’s list of ‘major players’ in the Point-of-Care/Point-of-Need healthcare diagnostics marketplace,” said Lyle Probst, President and CEO of ExcitePCR. “Through our predecessor company, we have been an active participant in identifying and measuring airborne pathogens like anthrax for over 10 years. With the recent advancements we’ve made to our FireflyDX™ technologies, we are looking forward to bringing our first PCR-based testing and diagnostics systems to market next year.”ExcitePCR’s first commercial product — the FireflyDX-Portable™ — is designed for use in several multi-billion-dollar industries (including medical testing and diagnostics), markets where molecular diagnostics are critical to ensure rapid safety and treatment protocols. Unfortunately, today’s existing solutions for accurately identifying potential pathogens and bio-threats, especially in-the-field at the Point-of-Care/Point-of-Need, can sometimes take as long as several hours to several days to provide results, dramatically delaying what is often life-saving treatment, while also increasing costs, both personal and financial. In addition, most state-of-the-art Polymerase Chain Reaction (PCR) solutions in use today for pathogen detection typically require a professionally trained operator working in a pristine laboratory setting and/or are heavy, bulky and tied to a personal computer to function properly.“By contrast,” Probst explained, “ExcitePCR’s FireflyDX-Portable is a standalone, knapsack-sized bio-threat detection system that can be operated by virtually anyone with minimal training yet still produces highly accurate results. In addition, the FireflyDX-Portable will deliver such results in under 30 minutes, including sample preparation (which generally takes the most time in pathogen detection).”About ExcitePCR Headquartered in Pleasanton, California, ExcitePCR Corporation is developing portable pathogen detection systems based upon superior sample preparation and realtime PCR (Polymerase Chain Reaction) methodologies. Its FireflyDX technologies will deliver rapid automated Point-of-Care/Point-of-Care (POC/PON) sample preparation and highly accurate biohazard identification in a fraction of the time currently possible using existing PCR-based solutions.ExcitePCR, FireflyDX and FireflyDX-Portable are trademarks of ExcitePCR Corporation. All other trademarks are the property of their respective owners.

Sharing your scoops to your social media accounts is a must to distribute your curated content. Not only will it drive traffic and leads through your content, but it will help show your expertise with your followers.

Integrating your curated content to your website or blog will allow you to increase your website visitors’ engagement, boost SEO and acquire new visitors. By redirecting your social media traffic to your website, Scoop.it will also help you generate more qualified traffic and leads from your curation work.

Distributing your curated content through a newsletter is a great way to nurture and engage your email subscribers will developing your traffic and visibility.
Creating engaging newsletters with your curated content is really easy.